SILVER SPRING, Md. , March 25, 2013 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) announced today that it received a second complete response letter from the United States Food and Drug Administration (FDA) declining to approve its new drug application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension (PAH).

Martine Rothblatt , Ph.D., Chairman and Chief Executive Officer of United Therapeutics commented, "We remain confident that oral treprostinil will play an important role in treating PAH and we are committed to working collaboratively with the FDA to accomplish this goal in the most timely and appropriate manner."

United Therapeutics intends to immediately request an "end of review" meeting with the FDA to discuss this complete response letter.

About United Therapeutics 

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening conditions.

Forward-looking Statements 

Statements included in this press release that are not historical in nature are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding United Therapeutics' future efforts to gain approval of oral treprostinil, the related timing of those efforts, and actions United Therapeutics may take in response to the FDA's complete response letter.   These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic reports filed with the Securities and Exchange Commission, that could cause actual results to differ materially from anticipated results. Consequently, such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in our periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of March 25, 2013, and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason. [uthr-g]

SOURCE United Therapeutics Corporation

Bayer HealthCare announced that it has submitted the oral investigational drug riociguat for treatment of patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) and pulmonary arterial hypertension (PAH) for approval in the United States and European Union.

“These regulatory submissions for two distinct forms of pulmonary hypertension not only represent important progress in our cardiovascular pipeline but also fuel our hope to bring this much-needed new treatment option for these serious and potentially fatal diseases to patients and doctors soon,” Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development said in a statement.

The drug represents the first member of a novel class of compounds known as the stimulators of soluble guanylate cyclase (sGC). According to the company, riociguat is the first drug to demonstrate clinical efficacy in a placebo controlled phase III trial in inoperable CTEPH patients.

Submission for approval was based off of data from two pivotal, global Phase III studies. Results from CHEST-1 and PATENT-1 were presented at the 2012 annual meeting of the American College of Chest Physicians (ACCP) in Atlanta. In both studies, riociguat met their primary endpoint in exercise capacity. The drug was generally well-tolerated. No unexpected adverse events were reported in both studies.

In the study CHEST-1, investigators found that patients who were treated with riociguat showed a statistically significant improvement from baseline in the six-minute walking test after 16 weeks compared to patients receiving the placebo. This study consisted of patients with inoperable CTEPH and patients with persistent or recurrent disease after pulmonary endarterectomy (PEA), a surgical procedure.

The PATENT-1 study showed a statistically significant improvement from baseline in the six minute walking test after twelve weeks versus those receiving the placebo. This study included both treatment naïve symptomatic PAH patients and those pre-treated with ERAs or non-iv prostanoid monotherapy.

Source: Bayer HealthCare

Last Updated: 2/12/13; 11:10AM EST

Today, the Swiss company Actelion announced that the Food and Drug Administration has agreed to evaluate the company’s Pulmonary Arterial Hypertension (PAH) drug macitentan. PAH, a lung condition that causes patients to experience high blood pressure in the arteries of the lungs, is a potentially life-threatening condition. Macitentan is intended to replace Tracleer, a current treatment for PAH that will lose its patent in 2015.

In October of this year, Actelion submitted their application to the FDA for macitentan. "Even though Opsumit did not receive priority review status the news of (new drug application) acceptance is positive and places the drug's launch to end of FY13," Vontobel analyst Andrew Weiss said in a note.

Tracleer, the current PAH treatment, faces competition from Letairis, a drug manufactured by Gilead. The drug review for macitentan by the FDA is expected to last 12 months, according to Actelion.

Today, Dr. Reddy’s Laboratories announced it has launched a generic drug for treatment of pulmonary arterial hypertension.

The announcement follows the US Food and Drug Administration’s (FDA) approval of Dr. Reddy’s Application for New Drug Approval (ANDA). The Sildenafil Tablets (20 mg) is the bioequivalent generic version of Pfizer’s Revatio®, whose patent recently expired. Mylan, Watson Pharmaceuticals, Apotex, and Torrent have also received FDA approval to market the generic version.

According to IMS Health, the Revatio® brand has sales of approximately $338.67 Million in the US in a 12-month period ending in September 2012.

Pfizer has also lost patent protection for the world’s top-selling drug Lipitor, used to fight cholesterol, as well as Geodon and Xalatan, which are all facing declining sales due to generic competition.

Dr. Reddy’s Sildenafil Tablets are available in 20 mg in a 90 count bottle size.

About Dr. Reddy’s
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management, anti-infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. For more information, log on to:
www.drreddys.com

Source: Dr. Reddy's Laboratories Ltd. 

Last Updated: 11/19/12; 3:35PM EST